ISO/TS 22002-1:2009

Dear Ken,

Thks for the comments. I deduce that you consider the 22002-1 standard a worthwhile document despite yr diversity caveats. Time will tell I suppose. It does seem remarkable to me that ISO which has been synonymous with generic quality standards has now become so malleable. Interesting times.

Rgds / Charles.C

Charles

You deduction is correct!

You have to look at this from a food safety perspective and not an ISO one. As Simon has already said, ISO 22000 without defined PRP's is 'next to useless as a food certification standard' and I must agree with him.

The requirements of safe food production must drive ISO food safety standards and not the other way round!

This is why auditors must have a strong food safety background - a food safety course lasting a few days might be a start for converting non food ISO auditors to ISO 22000 but is way short of the knowledge which is required when auditing in the food industry.

Dear All,

ISO 22000 without defined PRP's is 'next to useless

I am probably the very worst person to be a defender of iso 22000 but I think this is rather unfair, eg –

One of the differences between HACCP and ISO 22000 is the ISO standard’s emphasis of the use of prerequisite programs (PRPs). PRPs are generic controls used by any food business operation to maintain hygienic conditions in the processing environment. PRPs stipulate the preconditions necessary for producing safe food. Depending on the type of activity involved, the following defined requirements should be considered:
• Good Agricultural Practice (GAP)
• Good Hygienic Practice (GHP)
• Good Production Practice (GPP)
• Good Distribution Practice (GDP)
Additional components of prerequisite programs include, for example, cleaning and sanitizing; pest control; personnel hygiene; construction and layout of buildings and associated utilities; supplies of air, water, energy, and other utilities; supporting services such as waste and sewage disposal; supplier control; employee training; and more.

http://www.qualitydi...-iso-22000.html

Having now had a look at a summary of the iso 2002-1 sub-sections, I wonder if GFSI will now criticise this document as being over – prescriptive! Out of curiosity, I attempted on the iso website to find any indications of their thinking over the current issues in the context of maximising food safety but failed. I do wonder what the ISO perspective on all this is. Whatever, they certainly appear to be playing hardball now.

I also (very) crudely gauged the degree of explicitness of the GFSI Guidance ver 5 by doing a check of Part2- Annex1 for the appearance of the words “must”,"shall", “should”, and “appropriate”. The results were rather surprising IMO, namely: 1, 0, 210, 35. (the “1” was “Staff must be properly trained against the documented hygiene standards” and occurred in the GAP column, not GMP or GDP).

I liked the section on Auditor Behavioural Characteristics, no source given unfortunately -

7.5.8 Attributes and Competencies
The Certification Body must have a system in place to ensure auditors conduct themselves in a
professional manner. The following provide examples of required behaviour.

• Ethical, i.e. fair, truthful, sincere, honest and discreet.
• Open minded, i.e. willing to consider alternative ideas or points of view.
• Diplomatic, i.e. tactful in dealing with people.
• Observant, i.e. actually aware of physical surroundings and activities.
• Perceptive, i.e. instinctive, aware of and able to understand situations.
• Versatile, i.e. adjust readily to different situations.
• Tenacious, i.e. persistent, focussed on achieving objectives.
• Decisive, i.e. timely conclusions based on logical reasoning.
• Self reliant, i.e. acts independently whilst interacting effectively with others.
• Integrity – aware of need for confidentiality and observing professional code of conduct.

Still wondering what the “observant” one means.
I suppose aspects like “ should display appropriate knowledge” are taken as a prerequisite.

Rgds / Charles.C

Dear All,

I am probably the very worst person to be a defender of iso 22000 but I think this is rather unfair, eg –

OK a little harsh maybe but you are right in the that ISO 22000 does refer to PRP's. However, ISO 22002 gives a little bit more detail to at least give a basis of a common understanding.

If you take an area which I am less familiar with such as agricultural then I don't really know what the PRP's for this sector would be so a technical standard similar to ISO 22002-1 but aimed at the agricultural sector would be helpful to at least trying to get a common approach to auditing this sector of the food industry.

OK a little harsh maybe but you are right in the that ISO 22000 does refer to PRP's. However, ISO 22002 gives a little bit more detail to at least give a basis of a common understanding.

If you take an area which I am less familiar with such as agricultural then I don't really know what the PRP's for this sector would be so a technical standard similar to ISO 22002-1 but aimed at the agricultural sector would be helpful to at least trying to get a common approach to auditing this sector of the food industry.

Dear Ken,

I agree with you. We should not be so hard with ISO. Maybe the hole theme is a little bit complicated and "interlaced" but it is for common good. Many factories do not take into account some of the PRPs refered in ISO 22002. The main reason is that they can't think about it or they want to avoid it if it is not written. So some explainatory guidelines are always wellcomed.

Dear Ken,

It is possible that my previous post was poorly constructed and thereby misleading. My evaluation of GFSI was across the data in all three categories of GAP, GMP and GDP, it just happened that the one occurrence of "must" fell into the GAP category.

I suppose if nothing else, the current upheaval will generate a useful updated version of Codex / GMP. Pity it's not publicly available for free.

If anyone is interested in seeing the GFSI's original asessment of ISO 2200 (2007), see -

 GFSI_eval._iso_22000_.pdf   797.96KB   206 downloads


Rgds / Charles.C

Also I would like to know whether this renders PAS220 obsolete and whether FSSC 22000 will be using ISO/TS 22002-1:2009, PAS 220 or both / either. As well as whether this release has any impact (positive/negative) on FSSC 22000 itself.

Regards,
Simon

Hi Simon,

ISO/TS 220002-1:2009 can be used for FSSC see document attached. I don´t think it has a negative impact. Maybe PAS 220 will be in the market for a while until ISO/TS 220002-1:2009 takes its first steps.

 Changes.pdf   31.6KB   203 downloads

Should this topic be moved to FSSC 22000 forum?

Regards,

FSSM

Hi Simon,

ISO/TS 220002-1:2009 can be used for FSSC see document attached. I don´t think it has a negative impact. Maybe PAS 220 will be in the market for a while until ISO/TS 220002-1:2009 takes its first steps.

 Changes.pdf   31.6KB   203 downloads

Should this topic be moved to FSSC 22000 forum?

Regards,

FSSM

Thanks for that FSSM

I had a personal notification from FSSC but not seen any anouncements

Please can you tell us where did you get that FSSC 22000 changes document from and when?

Kind regards,

Tony

The changes can be found in:

http://www.fssc22000.com/page.php click [downloads] click [changes].

I think it is released on January 7th 2010.

Should this topic be moved to FSSC 22000 forum?

You're right FSSM. I moved it.

The changes can be found in:

http://www.fssc22000.com/page.php click [changes].

I think it is released on January 7th 2010.

Is the link correct Madam A. D-tor - I get a blank page?

Is the link correct Madam A. D-tor - I get a blank page?

You are right Simon. The link refers to several menu items. Just click doenloads and then click changes.

You are right Simon. The link refers to several menu items. Just click doenloads and then click changes.

For the lazy - FSSC 22000 Changes

Regards,
Simon

Dear vasman,

Thks for this interesting information and Welcome to the forum

Would be even more interesting if they issued some worked - out examples for Oprps ??!! Or perhaps a usable "Tree" ? Hopefully the Secretariat read this forum.

Rgds / Charles.C

Dear Charles and Vasman

I am so glad to hear your comments, specially Charles' ones.

I honestly believe that nobody ( auditors, quality manager, food consultant...) understand exactly what OPRP are or what is the purpose of that. Maybe only people who wrote it has a clear meaning of that, maybe not ?

I wonder what would happen if OPRP concept were eliminated from the standand. Do you really thing that food safety would be compromised? I do not think so.

I will like to share a experience with all you. I was asssisting an audit for BRC, IFS asn ISO 22000 certification. After finishing with BRC and IFS, time for ISO 22000 came out. The auditor asked for the OPRP. We had not establihed the OPRP in writting but I said " we had thought in these two but, which ones do you want they to be? Well, there was no answer from the auditor. No reply, no comments, no reasoning? ISO 22000 time finished at that moment.

Best regards
Esther

Dear Esther,

OPRPs are not that hard to understand. They are just all the points that did not become CCP and are not included in prerequisite programs. We used to call them CPs earlier. They are called General control measures in Dutch HACCP, CPs in IFs and process monitoring in BRC.
Perhaps you can remember that in the earlier days of HACCP, companies used to have over 10 CCPs. Nowadays they only have 2-4 CCPs. The other 6-8s can mostly considered as OPRP.

You have to control them, but not that hard as a CCP.

Dear Esther,

OPRPs are not that hard to understand. They are just all the points that did not become CCP and are not included in prerequisite programs. We used to call them CPs earlier. They are called General control measures in Dutch HACCP, CPs in IFs and process monitoring in BRC.
Perhaps you can remember that in the earlier days of HACCP, companies used to have over 10 CCPs. Nowadays they only have 2-4 CCPs. The other 6-8s can mostly considered as OPRP.

You have to control them, but not that hard as a CCP.

Agreed.

We use this simple system.

Assess the likelihood of the hazard occurring and enter:
- 1 for Highly Unlikely
- 2 for Possible
- 3 for Likely

Assess the severity of the hazard and enter:
- 1 for Not Severe
- 2 for Could possibly cause illness
- 3 for Severe (Could be fatal)

Multiply the two factors to get a hazard significance score. Significant Food Safety Hazards score a 9 and are assessed using the decision tree. If they are not judged to be CCP's then they are OPRP's.

Regards,

Tony

Thanks for that FSSM

I had a personal notification from FSSC but not seen any anouncements

Please can you tell us where did you get that FSSC 22000 changes document from and when?

Kind regards,

Tony

Well I found it at the link that Madam A. D-Tor (thanks for that) kindly posted the day I posted, January 29th.

Regards,

FSSM

Agreed.

We use this simple system.

Assess the likelihood of the hazard occurring and enter:
- 1 for Highly Unlikely
- 2 for Possible
- 3 for Likely

Assess the severity of the hazard and enter:
- 1 for Not Severe
- 2 for Could possibly cause illness
- 3 for Severe (Could be fatal)

Multiply the two factors to get a hazard significance score. Significant Food Safety Hazards score a 9 and are assessed using the decision tree. If they are not judged to be CCP's then they are OPRP's.

Regards,

Tony

I agree also with Madam A. D-tor and Tony-C, but I thought it wasn´t so well accepted that match, unless other has some arguments against it.

It is obvious the standar wasn´t clear enough to detail this, and that is what has gather so many critisism to ISO 22000. I´m sure that if you delete the concept of OPRP´s, nothing would happen, as Esther says, but it would be different to get rid off the programs under that name and maintain a FSMS, working for a long time without safety issues.

Regards,

FSSM

Hello Simon,

I believe with the release of ISO/TS 22002, ISO has just made GSFI's FSSC 22000 redundant. There is this "invisible" but a continuous warfare between these organizations with ISO attempting to remove private food safety standards and replacing it with ISO22000 as the global std. Frankly, if a consultant is adequately experienced in a specific industry, PAS 220 and ISO/TS 22002 are both not needed however IMO, it remains useful only to serve as a reference.

Cheers
Charles Chew

Hello Simon,

I believe with the release of ISO/TS 22002, ISO has just made GSFI's FSSC 22000 redundant. There is this "invisible" but a continuous warfare between these organizations with ISO attempting to remove private food safety standards and replacing it with ISO22000 as the global std. Frankly, if a consultant is adequately experienced in a specific industry, PAS 220 and ISO/TS 22002 are both not needed however IMO, it remains useful only to serve as a reference.

Cheers
Charles Chew

Hello Charles,

It remains to be seen how the war ends in the long run, for now only FSSC 22000 is GFSI approved although there does not seem to be anything stopping ISO 22000+ISO/TS 22002 from being approved. I'm sure out of all this eventually will come a common(ish) food safety management system standard(s) which should bring more clarity, less duplication, less cost and importantly safer food throughout the global food supply chain.

As always it's very nice to hear from you Charles.

Regards,
Simon

Dear Esther,

OPRPs are not that hard to understand. They are just all the points that did not become CCP and are not included in prerequisite programs. We used to call them CPs earlier. They are called General control measures in Dutch HACCP, CPs in IFs and process monitoring in BRC.
Perhaps you can remember that in the earlier days of HACCP, companies used to have over 10 CCPs. Nowadays they only have 2-4 CCPs. The other 6-8s can mostly considered as OPRP.

You have to control them, but not that hard as a CCP.

Dear Madam A

Thank you for your answer, that makes me feel even better.
As I said when telling my experience, we were having and IFS,BRC and ISO 22000 audit. As you said, we have established our CP for our process which were the two I said to the auditor.
And, coming back to an old issue, we did not get the ISO 22000 certificate but the IFS and BRC and I am sure that it was just because the auditor had no experience at all in the manufacuring process that she was auditing; or maybe because in our Manual the word " OPRP" was not there. I do not know what is worst.

As Charles says ahead "if a consultant is adequately experienced in a specific industry, PAS 220 and ISO/TS 22002 are both not needed however IMO, it remains useful only to serve as a reference".

By the way, Madam, I totally agree with you, it is an easy way to see it. But ,in my opinion, it is the way I do it, apart from that thinking you have to be very aware of the king of industry you are in before defining CP = OPRP. Of course, you should have experience on that proccess.

Again, it is a pleasure to share opinions with you all

Best regards
Esther

And, coming back to an old issue, we did not get the ISO 22000 certificate but the IFS and BRC and I am sure that it was just because the auditor had no experience at all in the manufacuring process that she was auditing; or maybe because in our Manual the word " OPRP" was not there. I do not know what is worst.

Dear Esther,

I am sorry, you did not get your ISO 22000 certificate.
I, am afraid to say. but I have also establish non conformities for ISO 22000, regarding missing OPRPs and PRPs. Not just because the words were not in the manual, but because these companies seems to not understand PRPs and OPRPs.

The first company hired a consultant. The consultant wrote a manual based on Dutch HACCP. There were no reference to OPRPs or PRPs or equivalant in the manual. First they referered to the CCPs, when asking for OPRPs. Later they came with a list OPRPs, which were actually PRPs (pest control, personal hygiene, training, etc.) I was not able to let them understand that this were PRPs. Finally I let them write down these 'OPRPs' with all the requirements of OPRPs (Monitoring methods, frequency, limits, corrective action, responsible person and records). Even then they did not understand their mistake, and the company was given a major on not having proper monitoring on the determined OPRPs. I should have given one on the lack of knowledge of the standard.

The second company was already certified for Dutch HACCP and BRC. There is more knowledge in this company and they actually did a good transition from Dutch HACCP to ISO 22000. The OPRPs were still called General measures (= name for OPRPs in Dutch HACCP) but this was justified in the manual. The PRPs were however not documented and when asking the QA manager only refers to the OPRPs. Later he came up with general wordings like GMPs. He could howeer not name the PRPs which were applied in his company. They get a minor for that. Just to help them understanding the ISO 22000. They pass for BRC.

The PRPs were however not documented and when asking the QA manager only refers to the OPRPs. Later he came up with general wordings like GMPs. He could howeer not name the PRPs which were applied in his company. They get a minor for that. Just to help them understanding the ISO 22000. They pass for BRC.

If these people have no PRP or GMP procedures I don't see how they can pass a BRC audit either. BRC requires a HACCP system based on CODEX principles

From CODEX GUIDELINES FOR THE APPLICATION OF THE HACCP SYSTEM

Prior to application of HACCP to any sector of the food chain, that sector should have in place prerequisite programs such as good hygienic practices according to the Codex General Principles of Food Hygiene

Regards,

Tony

Dear Madam

I can understand your point of view:

One thing is " missing things" or " have evidence that people in charge of keeping quality system working have a poor undertanding of it"

And another very different thing is: " have different names for the same thing" which shoud not be a problem for a competent auditor( not you of course, I can not give an opinion on an decision I have not been in) as long as all the food safety requirements are complied.

Regards
Esther

Dear All,

I only just noticed these last fascinating series of posts.

Personally, at first sight, the procedure mentioned to specify OPRPs which Tony proposed seems to me questionably aligned to the ISO 22000 standard (depending on how the CCP selection is made et seq, added - the cut-off for significant hazards should certainly minimise potential CCPs [sorry Tony, couldn't resist ] ). Nonetheless, I am happy if auditors accept it.

I had previously noted the sort of correspondence between the Dutch standard and ISO 22000 however the aspect of control measure assessment surely remains unique to ISO 22000 ? I fail to see how following the Dutch HACCP procedure can comply with the CCP / OPRP requirements of ISO 22000. (for example the Dutch definition of general control measure (2006) appears to be - "Control measures required In general, control by means of general control measures from the prerequisite programme will suffice"). Nonetheless, I am similarly again happy if auditors accept this.

Seems to further support the removal of OPRPS.

Rgds / Charles.C

added - After re-reading the last 10 posts or so, I am still rather shocked. Madame A.D-tor mentioned a nonconformity for lack of knowledge might hv been appropriate to one auditee. Perhaps it would be more accurate to award this prize to the ISO development team for creating such a textual monstrosity. The saddest part to me is that the logic of the FS control system (as I understand it) has genuine merit IMO but the implementation text in some critical places of 22000/22004 is incomprehensible. CP = OPRP is perhaps a deserved conclusion.

Dear All,

I realise this is essentially off-topic but the opportunity was irresistible.

Taken from one of Ken's earlier posts -

'Technical specifications shall be reviewed at least every three years to decide either to confirm the technical specification for a further three years, revise the technical specification, process it further to become an International Standard or withdraw the technical specification.

After six years, a technical specification shall be either converted into an International Standard or withdrawn'.

ISO/TS 22004 , First Edition, is dated 15th November, 2005

AFAIK, there is no 2nd ed. as yet.

So, 11 months to go. I do not think it will ever be a standard since the content, eg regarding the oprp / ccp aspects, seems to me to almost ridicule the elaborate (albeit blurred) procedure in the primary document ISO 22000. It also surely cannot be withdrawn ?. I presume it is permitted to be extended as a revised edition ? Or ISO may simply change the rules.

As a (long delayed) further comment to some of previous posts, one unavoidable conclusion IMO after a re-reading is that a variety of fundamentally different interpretations of the oprp / ccp requirements must be being accepted as valid by within the auditing genre. To illustrate - at one extreme, an oprp is being equated to a traditional, relatively insignificant control program / measure (CM) from a safety aspect, at the other it is identical to a CCP except that it cannot be continuously monitored!. This range of scope is simply amazing IMO and I find it difficult to believe that the 22000 standard intended such an implementation. The scope also seems somewhat paradoxical given the standards requirement of a proposed (oprp/ccp)-CM to show demonstrable capability of achieving (individually / in a combination) defined "acceptable levels" of a significant safety hazard risk.

Rgds / Charles.C

ISO/TS 22004 , First Edition, is dated 15th November, 2005
AFAIK, there is no 2nd ed. as yet.
So, 11 months to go. I do not think it will ever be a standard since the content, eg regarding the oprp / ccp aspects, seems to me to almost ridicule the elaborate (albeit blurred) procedure in the primary document ISO 22000. It also surely cannot be withdrawn ?. I presume it is permitted to be extended as a revised edition ? Or ISO may simply change the rules.


Rgds / Charles.C

Given the lack of depth of 22004 and the price of over £50GBP I am not sure anyone would want to buy a revised edition unless it was shown to be a significant improvement.

Regards,

Tony